Stress Related DisorderPhase 4AdjuvantNCT03600493
Adjuvant to General Anesthesia in Patients Undergoing Major Abdominal Surgeries
A Phase 4 study testing Dexmedetomidine and Lidocaine in people with Stress Related Disorder, run by Suez Canal University.
Trial summary
assessing the effect of perioperative infusion of Dexmedetomidine versus Lidocaine on neuro endocrine stress response to surgery and anesthesia Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Stress Related Disorder
- What is being tested?
- Dexmedetomidine and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both gender.
- Consent from patients about technique and nature of the study.
- Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II).
- Patients scheduled for major abdominal surgery.
Who cannot join
- Pre-operative regular medication with opioids and benzodiazepines, alcohol abuse, known sleep disturbance, known endocrine disease
- Known allergy to Dexmedetomidine or Lidocaine.
- History of endocrine disorders.
- Heart block greater than first degree.
- Medication known to affect the sympathetic response or hormonal secretion.
- Smokers.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Dexmedetomidine and Lidocaine as an Adjuvant to General Anesthesia in Patients Undergoing Major Abdominal Surgeries
assessing the effect of perioperative infusion of Dexmedetomidine versus Lidocaine on neuro endocrine stress response to surgery and anesthesia
Read the detailed description
Methodolgy
During the preoperative visit, the techniques will be explained to patients including benefits and complications.
- Pre-operative assessment:
- Medical history:
- Medical disorders as hypertension, diabetes, heart, chest, liver or kidney diseases.
- Past history of operations, hospitalization or blood transfusion.
- Past anesthetic history with impact on previous airway problems during previous surgeries, hypersensitivity to anesthetic medications, any previous post-operative complications that could be attributed to anesthesia.
- Family history for specific anesthetic problems like malignant hyperthermia.
- Physical examination:
- General examination, \& vital signs (heart rate, blood pressure, respiratory rate and temperature) in bed the night before operation
- Heart, chest and abdominal examinations
- Anesthetic assessment:
- Examination of the limbs for prediction of difficult cannulation.
- Airway assessment including:
- Thyromental distance
- Mallampatti score
- Neck and tempro-mandibular joint mobility
- Assessing the absence of deformities in the mandible, face, tongue, palate, teeth and neck that may interfere with airway management
- Laboratory investigations:
- Complete blood count
- Prothrombin time and partial tissue thromboplastic time
- Kidney function test (s, creatinine \& urea), Liver function test (ALT, AST, albumin and bilirubin) \& Random blood sugar.
- Serum Cortisol and IL6 level before starting drug infusion.
- Demographic data: The patient's age, sex, ASA status, and duration of surgery will be recorded.
- Technique:
- Patients will be fasting for 6 - 8 hours.
- All patients will receive oral midazolam (7.5 mg), and oral ranitidine (150mg) administered 90 min before arrival in the operating room with a sip of water.
- All patients will receive a pre-induction normal saline 10 ml/kg body weight over 10-15 minutes. Subsequently, intravenous fluid administration will be done according to the need of each patient.
- All operations will start between 08.30 am and 09.30 am, to minimize variations in cortisol level.
- All patients will receive the drug of study 10 min before induction of anesthesia till the start of wound closure in the form of: Group (D) Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the end of wound closure. Group (L) Lidocaine prepared in a syringe with the same volume of Dexmedetomidine to assure blinding given as 1mg/kg over 10 min followed by 1mg/kg/hr.
- Doses will be calculated, diluted in 50 ml of normal saline and given intravenously by a syringe pump over 10 minutes initially and then over 1hr till the start of wound closure.
- All drugs of the study will be prepared by an independent anesthesiologist who will not share in the study and then selected and given by another one blinded for the content of each syringe.
- Airway devices, anesthesia machine, ventilator, flowmeters and monitors will be checked promptly.
- Another wide-bore I.V cannula will be inserted in case of blood transfusion.
- Monitoring equipment's (Datex-Ohmeda™) will be attached to the patient including 3-leads ECG, non-invasive arterial blood pressure, pulse oximetery and capnograph after tracheal intubation.
- The depth of anesthesia will be monitored with Entropy device. The Entropy electrodes will be placed on the forehead and on the lateral angle of orbit and connected to (Datex-Ohmeda™) by a special. The target Entropy range will be 40-60 for surgical anesthesia.
- Induction of anesthesia will be performed by Propofol 2 mg/kg followed by cis-atracurium 0.15 mg/kg and fentanyl 1 mcg/kg given intravenously after pre-oxygenation with 100% oxygen for at least 3 minutes.
- Patients will be manually ventilated with 100% oxygen till intubation after 2 min and with Entropy value of 60 to 40 by Macintosh laryngoscope and appropriate size endotracheal tube.
- Maintenance of anesthesia will be carried out by isoflurane varying its end tidal concentration to keep Entropy in the range of 55 to 40 with Air:Oxygen mixture 0.3 fraction of oxygen and flow rate of 2 liter in completely closed circuit.
- Cis-atracurium 0.03 mg/kg guided by neuromuscular monitor Train of Four (TOF) will be used for muscle relaxation.
- Hemodynamics (mean arterial blood pressure and heart rate) will be maintained within 25 % of baseline measures.
- Any increase of MAP or HR more than 25% of baseline measures on two consecutive readings within 2-3 min will be managed by I.V bolus of fentanyl 0.5 mcg/kg and any decrease of MAP or HR less than 25 % on two consecutive readings within 2-3 min will be managed by I.V bolus of ephedrine 5 mg or atropine 0.5 mg respectively.
- The infusion of study medication will be discontinued if the hypotension persisted > 5 min after these interventions upon return of the MAP or HR to within 25% of the baseline value, the study medication infusion will be resumed at 50% of the initial infusion rate and then gradually increased to the initial infusion rate.
- The infusion of study medication will be discontinued at the start of wound closure. Upon completion of wound closure, isoflurane will be discontinued and the inspired oxygen flow rate will be increased to 5 L/min and residual neuromuscular block will be reversed with neostigmine, 0.05 mg/kg IV, and atropine 0.25 mg/kg, IV. The trachea will be extubated when the patient is fully awake. Transfer to the recovery room will be done when the patient scored 7 and above using the modified Aldrete scoring system.
- On emergence from anesthesia and immediately in post anesthesia care unit, analgesic regimen, consisting of intravenous patient-controlled morphine analgesia (bolus 1mg, 10-min lockout, maximum dose 5 mg / h), will be used in all groups.
- The whole technique and anesthetic procedures will be performed by the same anesthesiologist to avoid as much as possible the inter-individual skill variations.
- Conditions
- Stress Related Disorder
- Being tested
- Dexmedetomidine, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Selective Alpha 2 agonist
Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the start of wound closure.
LidocaineDrug
Also called Lignocaine
Lidocaine given as 1mg/kg over 10 min followed by 1mg/kg/hr till the start of wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Dexemetomidine | Active comparator | Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the start of wound closure. Receives: Drug: Dexmedetomidine |
| Lidocaine | Active comparator | Lidocaine prepared in a syringe with the same volume of Dexmedetomidine to assure blinding given as 1mg/kg over 10 min followed by 1mg/kg/hr till the start of wound closure. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Interleukin 6 (IL6)
Serum Interleukin 6 will be measured in picogram/Milliliter
Measured: Serum Interleukin 6 will be measured at baseline and then 2 hours after induction of surgery and then 6 hours postoperative
Secondary outcomes (7)
Change in Serum Cortisol
Measurement of Serum Cortisol levels in microgram/deciliter
Measured: Serum Cortisol will be measured as baseline and then 2 hours after induction of surgery and then 6 hours postoperative
Changes in Mean Arterial Blood Pressure (MABP)
MABP changes in mmHg with intubation, extubation and throughout surgery
Measured: Baseline MABP, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation
Changes in Heart Rate (HR)
HR changes with intubation, extubation and throughout surgery
Measured: Baseline HR, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation
Morphine consumption
Total postoperative morphine consumption in mg during first 24 hours
Measured: Morphine consumption during first 24 hours postoperatively
Ephedrine
Total Ephedrine dose in mg used intraoperative for treatment of hypotension
Measured: During intraoperative period
Atropine consumption using questionnaire
Total Atropine dose in mg used intraoperative for treatment of bradycardia
Measured: During intraoperative period
Visual analogue scale VAS
Pain scale measurement for postoperative assessment of pain consisting from 0 to 10 representing 0 as no pain and 10 as the most imaginable pain treating the patient if VAS > 3
Measured: VAS (visual analogue scale) at 1, 2, 4, 8, 12 and 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startAug 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Related DisorderStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed A Elsadany, MD, Suez Canal University
- Investigators
- Mohamed A Elsadany, MD, Principal investigator, Anesthesia and Intesive Care department, Faculty of Medicine, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600493
- Sponsor's protocol ID
- 3399
- Acronym
- Adjuvant
- Status last verified
- Aug 2018
- First submitted
- 2 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dexmedetomidine and Lidocaine as an Adjuvant to General Anesthesia in Patients Undergoing Major Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT03600493
- Acronym / sponsor ID
- Adjuvant / 3399
- Conditions
- Stress Related Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
assessing the effect of perioperative infusion of Dexmedetomidine versus Lidocaine on neuro endocrine stress response to surgery and anesthesia
Detailed description
Methodolgy
During the preoperative visit, the techniques will be explained to patients including benefits and complications.
- Pre-operative assessment:
- Medical history:
- Medical disorders as hypertension, diabetes, heart, chest, liver or kidney diseases.
- Past history of operations, hospitalization or blood transfusion.
- Past anesthetic history with impact on previous airway problems during previous surgeries, hypersensitivity to anesthetic medications, any previous post-operative complications that could be attributed to anesthesia.
- Family history for specific anesthetic problems like malignant hyperthermia.
- Physical examination:
- General examination, \& vital signs (heart rate, blood pressure, respiratory rate and temperature) in bed the night before operation
- Heart, chest and abdominal examinations
- Anesthetic assessment:
- Examination of the limbs for prediction of difficult cannulation.
- Airway assessment including:
- Thyromental distance
- Mallampatti score
- Neck and tempro-mandibular joint mobility
- Assessing the absence of deformities in the mandible, face, tongue, palate, teeth and neck that may interfere with airway management
- Laboratory investigations:
- Complete blood count
- Prothrombin time and partial tissue thromboplastic time
- Kidney function test (s, creatinine \& urea), Liver function test (ALT, AST, albumin and bilirubin) \& Random blood sugar.
- Serum Cortisol and IL6 level before starting drug infusion.
- Demographic data: The patient's age, sex, ASA status, and duration of surgery will be recorded.
- Technique:
- Patients will be fasting for 6 - 8 hours.
- All patients will receive oral midazolam (7.5 mg), and oral ranitidine (150mg) administered 90 min before arrival in the operating room with a sip of water.
- All patients will receive a pre-induction normal saline 10 ml/kg body weight over 10-15 minutes. Subsequently, intravenous fluid administration will be done according to the need of each patient.
- All operations will start between 08.30 am and 09.30 am, to minimize variations in cortisol level.
- All patients will receive the drug of study 10 min before induction of anesthesia till the start of wound closure in the form of: Group (D) Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the end of wound closure. Group (L) Lidocaine prepared in a syringe with the same volume of Dexmedetomidine to assure blinding given as 1mg/kg over 10 min followed by 1mg/kg/hr.
- Doses will be calculated, diluted in 50 ml of normal saline and given intravenously by a syringe pump over 10 minutes initially and then over 1hr till the start of wound closure.
- All drugs of the study will be prepared by an independent anesthesiologist who will not share in the study and then selected and given by another one blinded for the content of each syringe.
- Airway devices, anesthesia machine, ventilator, flowmeters and monitors will be checked promptly.
- Another wide-bore I.V cannula will be inserted in case of blood transfusion.
- Monitoring equipment's (Datex-Ohmeda™) will be attached to the patient including 3-leads ECG, non-invasive arterial blood pressure, pulse oximetery and capnograph after tracheal intubation.
- The depth of anesthesia will be monitored with Entropy device. The Entropy electrodes will be placed on the forehead and on the lateral angle of orbit and connected to (Datex-Ohmeda™) by a special. The target Entropy range will be 40-60 for surgical anesthesia.
- Induction of anesthesia will be performed by Propofol 2 mg/kg followed by cis-atracurium 0.15 mg/kg and fentanyl 1 mcg/kg given intravenously after pre-oxygenation with 100% oxygen for at least 3 minutes.
- Patients will be manually ventilated with 100% oxygen till intubation after 2 min and with Entropy value of 60 to 40 by Macintosh laryngoscope and appropriate size endotracheal tube.
- Maintenance of anesthesia will be carried out by isoflurane varying its end tidal concentration to keep Entropy in the range of 55 to 40 with Air:Oxygen mixture 0.3 fraction of oxygen and flow rate of 2 liter in completely closed circuit.
- Cis-atracurium 0.03 mg/kg guided by neuromuscular monitor Train of Four (TOF) will be used for muscle relaxation.
- Hemodynamics (mean arterial blood pressure and heart rate) will be maintained within 25 % of baseline measures.
- Any increase of MAP or HR more than 25% of baseline measures on two consecutive readings within 2-3 min will be managed by I.V bolus of fentanyl 0.5 mcg/kg and any decrease of MAP or HR less than 25 % on two consecutive readings within 2-3 min will be managed by I.V bolus of ephedrine 5 mg or atropine 0.5 mg respectively.
- The infusion of study medication will be discontinued if the hypotension persisted > 5 min after these interventions upon return of the MAP or HR to within 25% of the baseline value, the study medication infusion will be resumed at 50% of the initial infusion rate and then gradually increased to the initial infusion rate.
- The infusion of study medication will be discontinued at the start of wound closure. Upon completion of wound closure, isoflurane will be discontinued and the inspired oxygen flow rate will be increased to 5 L/min and residual neuromuscular block will be reversed with neostigmine, 0.05 mg/kg IV, and atropine 0.25 mg/kg, IV. The trachea will be extubated when the patient is fully awake. Transfer to the recovery room will be done when the patient scored 7 and above using the modified Aldrete scoring system.
- On emergence from anesthesia and immediately in post anesthesia care unit, analgesic regimen, consisting of intravenous patient-controlled morphine analgesia (bolus 1mg, 10-min lockout, maximum dose 5 mg / h), will be used in all groups.
- The whole technique and anesthetic procedures will be performed by the same anesthesiologist to avoid as much as possible the inter-individual skill variations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexemetomidine | Active comparator | Drug: DexmedetomidineDexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the start of wound closure. |
| Lidocaine | Active comparator | Drug: LidocaineLidocaine prepared in a syringe with the same volume of Dexmedetomidine to assure blinding given as 1mg/kg over 10 min followed by 1mg/kg/hr till the start of wound closure. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both gender.
- Consent from patients about technique and nature of the study.
- Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II).
- Patients scheduled for major abdominal surgery.
Key exclusion criteria (6 listed)
- Pre-operative regular medication with opioids and benzodiazepines, alcohol abuse, known sleep disturbance, known endocrine disease
- Known allergy to Dexmedetomidine or Lidocaine.
- History of endocrine disorders.
- Heart block greater than first degree.
- Medication known to affect the sympathetic response or hormonal secretion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Selective Alpha 2 agonistDexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the start of wound closure. | Drug | Dexemetomidine |
| LidocaineAlso: LignocaineLidocaine given as 1mg/kg over 10 min followed by 1mg/kg/hr till the start of wound closure. | Drug | Lidocaine |
Primary outcome
Change in Serum Interleukin 6 (IL6)
Time frame: Serum Interleukin 6 will be measured at baseline and then 2 hours after induction of surgery and then 6 hours postoperative
Serum Interleukin 6 will be measured in picogram/Milliliter
7 secondary outcomes
Change in Serum Cortisol
Time frame: Serum Cortisol will be measured as baseline and then 2 hours after induction of surgery and then 6 hours postoperative
Changes in Mean Arterial Blood Pressure (MABP)
Time frame: Baseline MABP, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation
Changes in Heart Rate (HR)
Time frame: Baseline HR, immediately before induction and 1, 2, 3 and 5 min after intubation, then immediately before extubation, 1, 2, 3 and 5 min after extubation
Morphine consumption
Time frame: Morphine consumption during first 24 hours postoperatively
Ephedrine
Time frame: During intraoperative period
Atropine consumption using questionnaire
Time frame: During intraoperative period
Visual analogue scale VAS
Time frame: VAS (visual analogue scale) at 1, 2, 4, 8, 12 and 24 hours postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A Elsadany, MD principal investigator
Anesthesia and Intesive Care department, Faculty of Medicine, Suez Canal University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Lidocaine in people with Stress Related Disorder, run by Suez Canal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A Elsadany, MD (00966541738161, Sadany20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Interleukin 6 (IL6) (time frame: Serum Interleukin 6 will be measured at baseline and then 2 hours after induction of surgery and then 6 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.